Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2025-12-17 @ 8:59 AM
Study NCT ID:
NCT06398548
Status:
None
Last Update Posted:
2024-05-08 00:00:00
First Post:
2024-05-01 00:00:00
Brief Title:
Impact of Exercise Intensity on Fitness, Extracellular Vesicles, Inflammation, and Metabolism
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The Impact of 6 Weeks of Moderate- and Heavy-intensity Continous Training on Peak Oxygen Uptake, Plasma Extracellular Vesicles and Inflammatory Cytokines
Status:
None
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEX
Brief Summary:
This study is being carried out by the Exercise Metabolism and Inflammation Laboratory at the University of British Columbia campus in Kelowna, British Columbia. Participants who have met the inclusion criteria will first complete an informed consent form. Participants will also complete forms to determine their level of activity. Females will also complete a menstrual cycle questionnaire - but will not be required to start on a particular day in their cycle. Participants will have their anthropometrics recorded (height, weight, body composition), will provide a fasted blood sample, and undergo a maximal staged exercise test to determine their lactate threshold and their maximal oxygen uptake (VO2peak).
The blood test will be used to measure various markers. First, whole blood will be analyzed on a standard hematology analyzer to determine white blood cell counts, red blood cell counts, hemoglobin and platelets. Secondly, blood samples will be spun down to platelet poor plasma and stored for batch analysis. Analysis of plasma will include measurement of plasma cytokines: Interleukin (IL)-6, IL-10, IL-1 receptor agonist, tumor necrosis factor alpha (TNF-alpha) and plasma extracellular vesicles. Extracellular vesicles (EVs) will be isolated using size exclusion chromatography (SEC) and measured for size and concentration using tunable resistive pulse sensing (Izon Exoid, Izon USA). EV phenotype and origin will be determined using nano-flow cytometry (CytoFlex S, Beckman Coulter, USA). EV micro ribonucleic acid (miRNA) will be determined by extracting miRNA from isolated and concentrated EVs (high speed centrifugation of 25,000 x g for 1 hour at 20 degrees Celsius). Extracted miRNA will be measured using PCR (BioRad, USA).
The maximal exercise will occur on a stationary cycle ergometer (Lode Excalibur, Lode, The Netherlands). The ergometer is adjusted to be ideal for each participant. Participants are fitted with a chest strap heart rate monitor (Polar, Finland) and fitted with a face mask to collect to determine the amount of O2 consumption, and CO2¬ production. Lactate measures will be collected from fingertip capillary blood and measured with a lactate analyzer (Nova, USA) during the last 30 seconds of each stage, as is a rating of perceived exertion (RPE). The protocol involves remaining stationary on the ergometer for 2 minutes. Following baseline measures, participants will complete 2 minutes of warm up at 50 watts (W), and then 3-minute stages at consecutively higher workloads (20W increases for females, 30W increases for males). Participants cycle at 60 - 80 revolutions per minute (rpm) for as long as they can. Once they fall below, or cannot maintain a minimum of 50rpm, the test is terminated.
Following the test, the lactate threshold determined as a weighted combination of the log-log method, and Dmax method will be calculated. Weighting consists of 75% of the log-log value and 25% of the Dmax value as calculated in the "lactater" R package. Using their lactate thresholds, specific exercise prescriptions are determined.
Group randomization is completed using a 2:2:1 ratio of moderate intensity continuous training (MICT), heavy intensity continuous training (HICT) and control (CTRL). A power calculation using an alpha of 0.05, power of 0.8 and a medium effect size using changes in VO2peak within the literature suggest that 52 participants will need to complete the study.
For the MICT group, participants will cycle at the resistance associated with 70% of the resistance at their first lactate threshold (LT1) such that if their lactate threshold occurred at 110W, they would initially cycle at 77W (0.7 \* 110W). In the HICT group, the participants will cycle at the delta 10% of their lactate threshold and highest achieved resistance at the end of the test. As an example, a participant with a lactate threshold at 110W, who made it to 260W, would cycle at 125W (260W - 110W = 150W), (150W \* 0.1 = 15W), (15W + 110W= 125W). Each allocation is matched for energy expenditure, such that males will expend 350 kcals and females will expend 300 kcals.
As the participant progresses through the trial, they will experience an increase in resistance as they adapt to the training protocol. The lactate value associated with their allocation will be maintained throughout. For example, in the 2nd week, if their lactate falls by 10% or more, their resistance will be increased by 10%. The time of each session will also be modified based on the VO2 value associated with their threshold test.
Following the last session of their participation, we will schedule their post test to fall on what would normally be date of their next session. Furthermore, all post testing is completed between 48 and 72 hours following their last session. The post-test and pre-test are identical in nature.
The blood test will be used to measure various markers. First, whole blood will be analyzed on a standard hematology analyzer to determine white blood cell counts, red blood cell counts, hemoglobin and platelets. Secondly, blood samples will be spun down to platelet poor plasma and stored for batch analysis. Analysis of plasma will include measurement of plasma cytokines: Interleukin (IL)-6, IL-10, IL-1 receptor agonist, tumor necrosis factor alpha (TNF-alpha) and plasma extracellular vesicles. Extracellular vesicles (EVs) will be isolated using size exclusion chromatography (SEC) and measured for size and concentration using tunable resistive pulse sensing (Izon Exoid, Izon USA). EV phenotype and origin will be determined using nano-flow cytometry (CytoFlex S, Beckman Coulter, USA). EV micro ribonucleic acid (miRNA) will be determined by extracting miRNA from isolated and concentrated EVs (high speed centrifugation of 25,000 x g for 1 hour at 20 degrees Celsius). Extracted miRNA will be measured using PCR (BioRad, USA).
The maximal exercise will occur on a stationary cycle ergometer (Lode Excalibur, Lode, The Netherlands). The ergometer is adjusted to be ideal for each participant. Participants are fitted with a chest strap heart rate monitor (Polar, Finland) and fitted with a face mask to collect to determine the amount of O2 consumption, and CO2¬ production. Lactate measures will be collected from fingertip capillary blood and measured with a lactate analyzer (Nova, USA) during the last 30 seconds of each stage, as is a rating of perceived exertion (RPE). The protocol involves remaining stationary on the ergometer for 2 minutes. Following baseline measures, participants will complete 2 minutes of warm up at 50 watts (W), and then 3-minute stages at consecutively higher workloads (20W increases for females, 30W increases for males). Participants cycle at 60 - 80 revolutions per minute (rpm) for as long as they can. Once they fall below, or cannot maintain a minimum of 50rpm, the test is terminated.
Following the test, the lactate threshold determined as a weighted combination of the log-log method, and Dmax method will be calculated. Weighting consists of 75% of the log-log value and 25% of the Dmax value as calculated in the "lactater" R package. Using their lactate thresholds, specific exercise prescriptions are determined.
Group randomization is completed using a 2:2:1 ratio of moderate intensity continuous training (MICT), heavy intensity continuous training (HICT) and control (CTRL). A power calculation using an alpha of 0.05, power of 0.8 and a medium effect size using changes in VO2peak within the literature suggest that 52 participants will need to complete the study.
For the MICT group, participants will cycle at the resistance associated with 70% of the resistance at their first lactate threshold (LT1) such that if their lactate threshold occurred at 110W, they would initially cycle at 77W (0.7 \* 110W). In the HICT group, the participants will cycle at the delta 10% of their lactate threshold and highest achieved resistance at the end of the test. As an example, a participant with a lactate threshold at 110W, who made it to 260W, would cycle at 125W (260W - 110W = 150W), (150W \* 0.1 = 15W), (15W + 110W= 125W). Each allocation is matched for energy expenditure, such that males will expend 350 kcals and females will expend 300 kcals.
As the participant progresses through the trial, they will experience an increase in resistance as they adapt to the training protocol. The lactate value associated with their allocation will be maintained throughout. For example, in the 2nd week, if their lactate falls by 10% or more, their resistance will be increased by 10%. The time of each session will also be modified based on the VO2 value associated with their threshold test.
Following the last session of their participation, we will schedule their post test to fall on what would normally be date of their next session. Furthermore, all post testing is completed between 48 and 72 hours following their last session. The post-test and pre-test are identical in nature.
Detailed Description:
This study is being carried out by the Exercise Metabolism and Inflammation Laboratory at the University of British Columbia campus in Kelowna British Columbia Participants who have met the inclusion criteria will first complete an informed consent form Participants will also complete forms to determine their level of activity Females will also complete a menstrual cycle questionnaire - but will not be required to start on a particular day in their cycle Participants will have their anthropometrics recorded height weight body composition will provide a fasted blood sample and undergo a maximal staged exercise test to determine their lactate threshold and their maximal oxygen uptake VO2peak
The blood test will be used to measure various markers First whole blood will be analyzed on a standard hematology analyzer to determine white blood cell counts red blood cell counts hemoglobin and platelets Secondly blood samples will be spun down to platelet poor plasma and stored for batch analysis Analysis of plasma will include measurement of plasma cytokines Interleukin IL-6 IL-10 IL-1 receptor agonist tumor necrosis factor alpha TNF-alpha and plasma extracellular vesicles Extracellular vesicles EVs will be isolated using size exclusion chromatography SEC and measured for size and concentration using tunable resistive pulse sensing Izon Exoid Izon USA EV phenotype and origin will be determined using nano-flow cytometry CytoFlex S Beckman Coulter USA EV micro ribonucleic acid miRNA will be determined by extracting miRNA from isolated and concentrated EVs high speed centrifugation of 25000 x g for 1 hour at 20 degrees Celsius Extracted miRNA will be measured using PCR BioRad USA
The maximal exercise will occur on a stationary cycle ergometer Lode Excalibur Lode The Netherlands The ergometer is adjusted to be ideal for each participant Participants are fitted with a chest strap heart rate monitor Polar Finland and fitted with a face mask to collect to determine the amount of O2 consumption and CO2 production Lactate measures will be collected from fingertip capillary blood and measured with a lactate analyzer Nova USA during the last 30 seconds of each stage as is a rating of perceived exertion RPE The protocol involves remaining stationary on the ergometer for 2 minutes Following baseline measures participants will complete 2 minutes of warm up at 50 watts W and then 3-minute stages at consecutively higher workloads 20W increases for females 30W increases for males Participants cycle at 60 - 80 revolutions per minute rpm for as long as they can Once they fall below or cannot maintain a minimum of 50rpm the test is terminated
Following the test the lactate threshold determined as a weighted combination of the log-log method and Dmax method will be calculated Weighting consists of 75 of the log-log value and 25 of the Dmax value as calculated in the lactater R package Using their lactate thresholds specific exercise prescriptions are determined
Group randomization is completed using a 221 ratio of moderate intensity continuous training MICT heavy intensity continuous training HICT and control CTRL A power calculation using an alpha of 005 power of 08 and a medium effect size using changes in VO2peak within the literature suggest that 52 participants will need to complete the study
For the MICT group participants will cycle at the resistance associated with 70 of the resistance at their first lactate threshold LT1 such that if their lactate threshold occurred at 110W they would initially cycle at 77W 07 110W In the HICT group the participants will cycle at the delta 10 of their lactate threshold and highest achieved resistance at the end of the test As an example a participant with a lactate threshold at 110W who made it to 260W would cycle at 125W 260W - 110W 150W 150W 01 15W 15W 110W 125W Each allocation is matched for energy expenditure such that males will expend 350 kcals and females will expend 300 kcals
As the participant progresses through the trial they will experience an increase in resistance as they adapt to the training protocol The lactate value associated with their allocation will be maintained throughout For example in the 2nd week if their lactate falls by 10 or more their resistance will be increased by 10 The time of each session will also be modified based on the VO2 value associated with their threshold test
Following the last session of their participation we will schedule their post test to fall on what would normally be date of their next session Furthermore all post testing is completed between 48 and 72 hours following their last session The post-test and pre-test are identical in nature
The blood test will be used to measure various markers First whole blood will be analyzed on a standard hematology analyzer to determine white blood cell counts red blood cell counts hemoglobin and platelets Secondly blood samples will be spun down to platelet poor plasma and stored for batch analysis Analysis of plasma will include measurement of plasma cytokines Interleukin IL-6 IL-10 IL-1 receptor agonist tumor necrosis factor alpha TNF-alpha and plasma extracellular vesicles Extracellular vesicles EVs will be isolated using size exclusion chromatography SEC and measured for size and concentration using tunable resistive pulse sensing Izon Exoid Izon USA EV phenotype and origin will be determined using nano-flow cytometry CytoFlex S Beckman Coulter USA EV micro ribonucleic acid miRNA will be determined by extracting miRNA from isolated and concentrated EVs high speed centrifugation of 25000 x g for 1 hour at 20 degrees Celsius Extracted miRNA will be measured using PCR BioRad USA
The maximal exercise will occur on a stationary cycle ergometer Lode Excalibur Lode The Netherlands The ergometer is adjusted to be ideal for each participant Participants are fitted with a chest strap heart rate monitor Polar Finland and fitted with a face mask to collect to determine the amount of O2 consumption and CO2 production Lactate measures will be collected from fingertip capillary blood and measured with a lactate analyzer Nova USA during the last 30 seconds of each stage as is a rating of perceived exertion RPE The protocol involves remaining stationary on the ergometer for 2 minutes Following baseline measures participants will complete 2 minutes of warm up at 50 watts W and then 3-minute stages at consecutively higher workloads 20W increases for females 30W increases for males Participants cycle at 60 - 80 revolutions per minute rpm for as long as they can Once they fall below or cannot maintain a minimum of 50rpm the test is terminated
Following the test the lactate threshold determined as a weighted combination of the log-log method and Dmax method will be calculated Weighting consists of 75 of the log-log value and 25 of the Dmax value as calculated in the lactater R package Using their lactate thresholds specific exercise prescriptions are determined
Group randomization is completed using a 221 ratio of moderate intensity continuous training MICT heavy intensity continuous training HICT and control CTRL A power calculation using an alpha of 005 power of 08 and a medium effect size using changes in VO2peak within the literature suggest that 52 participants will need to complete the study
For the MICT group participants will cycle at the resistance associated with 70 of the resistance at their first lactate threshold LT1 such that if their lactate threshold occurred at 110W they would initially cycle at 77W 07 110W In the HICT group the participants will cycle at the delta 10 of their lactate threshold and highest achieved resistance at the end of the test As an example a participant with a lactate threshold at 110W who made it to 260W would cycle at 125W 260W - 110W 150W 150W 01 15W 15W 110W 125W Each allocation is matched for energy expenditure such that males will expend 350 kcals and females will expend 300 kcals
As the participant progresses through the trial they will experience an increase in resistance as they adapt to the training protocol The lactate value associated with their allocation will be maintained throughout For example in the 2nd week if their lactate falls by 10 or more their resistance will be increased by 10 The time of each session will also be modified based on the VO2 value associated with their threshold test
Following the last session of their participation we will schedule their post test to fall on what would normally be date of their next session Furthermore all post testing is completed between 48 and 72 hours following their last session The post-test and pre-test are identical in nature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None